CDSCO License for Cranial bur,
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue.
Comprehensive Guide to CDSCO Licensing for Cranial Bur (Class A Neurological Device)
As a medical device regulatory consultancy with over 25 years of experience and having supported 500+ companies in India, we understand the critical importance of navigating the CDSCO licensing framework efficiently. This guide focuses on the Cranial bur, a Class A neurological device intended for excavating skull tissue using a powered handpiece. We provide a detailed roadmap to secure the CDSCO manufacturing license (MD5) tailored specifically for this device, ensuring compliance while minimizing delays and costs.
Understanding the Cranial Bur and Its Regulatory Significance
The Cranial bur is a precision surgical instrument designed to fit into powered handpieces, facilitating the removal of soft or hard skull tissue in neurological procedures. Being a Class A medical device, it is considered low risk but still requires strict adherence to Indian regulatory standards to guarantee safety and efficacy for patients.
The device falls under the neurological category and is governed by the regulatory notification 29/Misc/03/2020-DC (201) dated 27.09.2021, which outlines specific compliance requirements.
CDSCO Regulatory Framework for Cranial Bur (Class A Device)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules 2017. For Class A devices like the Cranial bur, the licensing authority is the State Licensing Authority, which grants the MD5 license (Manufacturing license for Class A & B devices).
Manufacturers must comply with the following key steps:
- Obtain a Test License (MD13) before the manufacturing license application
- Complete product testing at CDSCO-approved laboratories
- Prepare comprehensive documentation including Device Master File and Plant Master File
- Undergo audit by a notified body
- Address any queries from CDSCO or the notified body
Risk Classification and License Requirements for Cranial Bur
The Cranial bur is classified as Class A, the lowest risk category, but the regulatory rigor remains stringent. The licensing process involves:
| License Type | Applicable To | Application Form | Licensing Authority | Timeline | Fees (INR) |
|---|---|---|---|---|---|
| MD5 | Class A & B Manufacturing | MD3 | State Licensing Authority | 3-4 months total | Rs 5,000 + Rs 500 per product |
| MD13 | Test License | MD13 | State Licensing Authority | 1.5-2 months | Rs 1,000 approx (varies) |
Step-by-Step Manufacturing License Process for Cranial Bur
Apply for Test License (Form MD13):
- Submit initial application via the CDSCO MD Online Portal.
- This license permits product testing at government-approved labs.
- Expect processing time of 1.5 to 2 months.
Product Testing:
- Get the Cranial bur tested for safety, biocompatibility, and performance parameters.
- Use CDSCO-recognized testing laboratories (Testing Laboratories List) for compliance.
Documentation Preparation:
- Compile a detailed Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
- Our comprehensive Device Master File guide can assist in preparation.
Submit Manufacturing License Application (Form MD3) for MD5:
- Upload all required documents including company constitution, proof of premises ownership, technical staff qualifications, Fire NOC, Pollution NOC, test reports, labels, and Instructions for Use (IFU).
Audit by Notified Body:
- The State Licensing Authority will appoint a notified body (refer to the Notified Bodies List) to conduct an audit of manufacturing facilities and QMS.
- The audit ensures compliance with Good Manufacturing Practices and safety standards.
Queries Resolution:
- Timely address any queries or clarifications raised by CDSCO or the notified body post-audit to avoid delays.
License Grant (Form MD5):
- Upon satisfactory review and audit, the State Licensing Authority will grant the manufacturing license.
Detailed List of Documents Required for MD5 License for Cranial Bur
- Company Constitution Documents (e.g., MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification Certificates of Technical Staff
- Fire and Pollution NOCs
- Device Master File (including design, specifications, intended use, labeling)
- Plant Master File (manufacturing processes, equipment, quality control)
- Essential Principles Checklist (compliance with Indian Medical Device Rules)
- Risk Management File (identifying and mitigating risks associated with the device) Risk Management Resource
- Test Reports from CDSCO-Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documentation (ISO 13485 certification preferred but not mandatory for Class A)
Import License Process for Cranial Bur (If Applicable)
For importers, the license required is the MD15 license, granted by the Central Licensing Authority. The process involves documentation preparation and application submission via the CDSCO portal with an approximate timeline of 5-6 months.
Required documents include the manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) Processing | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| Application Processing (MD5) | 1.5 to 2 months |
| Audit and Query Resolution | 2 to 4 weeks |
| Total Estimated Time | 3 to 4 months |
Government Fees and Cost Breakdown
| Fee Type | Amount (INR) |
|---|---|
| MD5 License Application | Rs 5,000 per application |
| Per Product Fee | Rs 500 per product |
| Test License (MD13) Fee | Approx Rs 1,000 |
| Notified Body Audit Fees | Variable (approx Rs 50,000 to Rs 75,000, paid separately) |
Note: Additional costs may include testing fees, document preparation fees if outsourced, and consultant charges.
Common Challenges and Practical Solutions
- Delayed Test License Approvals: Applying early and ensuring all documents are complete reduces wait times.
- Inadequate Testing Data: Use only CDSCO-recognized labs to avoid rejection.
- Incomplete Documentation: Leverage checklists and expert consultation to ensure submission completeness.
- Audit Non-compliance: Conduct internal mock audits before notified body visits.
- Query Delays: Assign a dedicated person to handle and respond promptly.
Expert Consultation and Support
With our extensive experience assisting over 500 companies, we provide end-to-end support including:
- Preparing and reviewing Device and Plant Master Files
- Coordinating product testing with approved labs
- Managing test license and manufacturing license applications
- Facilitating notified body audits and compliance training
- Post-licensing regulatory support and renewals
Getting Started with Your CDSCO License Application for Cranial Bur
- Register on the CDSCO MD Online Portal.
- Apply for the Test License (Form MD13) immediately to initiate product testing.
- Begin compiling your Device Master File and Plant Master File documents in parallel.
- Engage with a notified body early to understand audit expectations and schedule.
- Plan for adequate timelines and budget based on the outlined fees and process durations.
- Consult with regulatory experts to streamline your application and avoid common pitfalls.
Embarking on the CDSCO licensing journey for your Cranial bur device requires careful planning, thorough documentation, and proactive engagement with regulatory authorities. Leveraging our expertise ensures a smoother path to market entry, enabling you to focus on innovation and patient safety.
For detailed assistance and personalized support, contact us to discuss your Cranial bur manufacturing license requirements and start your application process today.
